• Regulatory NewsRegulatory News

    Democrats, Republicans Unveil Drug Pricing Bills

    As a new Congressional term kicks off, Democrats and Republicans in Congress, as well as the Trump administration, are pushing policies to lower prescription drug prices.   On Wednesday, Sens. Chuck Grassley (R-IA) and Amy Klobuchar (D-MN) introduced a bill, dubbed the Safe and Affordable Drugs from Canada Act of 2019, that would allow for Americans to import drugs from Canada. The bill mirrors the bill by the same name championed by the late Sen. John McCain (R-AZ...
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    FDA's Record Year: A Look at 2018 New Drug Approvals

    The US Food and Drug Administration (FDA) set an all-time record for new drug approvals in 2018 with 59 novel drugs and biologics approved by the agency's Center for Drug Evaluation and Research (CDER).   The number of new molecular entities (NMEs) and biologics approved by CDER surpassed the agency's previous record of 53 approvals in 1996 and is a significant jump over the 46 new drugs approved in 2017 . Those figures do not include products approved by FDA's Center...
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    EMA Recommends When Drugmakers Should Consult With Pediatric Research Network

    The European Medicines Agency (EMA) on Monday released recommendations from its European network of pediatric research (Enpr)-EMA working group on opportunities during various stages of development to consult with pediatric research groups.   “Enpr-EMA suggests that all companies consider using these opportunities in a spirit of shared learning about the best way to collaborate during [pediatric investigation plan] planning,” EMA writes, noting that companies can benef...
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    Generic Drug Prices ‘Strongly Predictive’ of Shortages, Study Finds

    How a generic drug is priced may be the difference between whether it experiences a shortage or not, a new study published in Value in Health found. The study of commonly used outpatient generic drugs from 2008 to 2014 found that the prevalence of shortages decreased from a peak in 2011-2012 to less than 4% of the overall sample by the end of 2014. Generic drug prices “were strongly predictive of drug shortages,” the researchers found. But competition and market si...
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    GAO Raises Questions on FDA’s Orphan Drug Designation Process

    The Government Accountability Office (GAO) announced Friday that it has found that the US Food and Drug Administration (FDA) does not always ensure that all information is consistently recorded and evaluated when making orphan drug designation determinations. The missing of these critical steps by the agency in some cases means that FDA reviewers do not fully understand the context of a drug’s intended use for the rare disease, GAO said. “The Commissioner of FDA shou...
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    FDA Spotlights Recent Spike in Drug Shortages

    The US Food and Drug Administration (FDA) is not just seeing an increase in drug shortages but also a spike in the intensity and duration of shortages, according to agency presentations at an FDA/Duke Margolis Center for Health Policy event on Tuesday. Matthew Rosenberg, an economics staffer at FDA, looked at drug shortages in terms of occurrence, duration, intensity and public health impact. Combining data from FDA archives and IQVIA national sales database, Rosenbe...
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    FDA Works to Reduce Dog Testing in Drug Development

    US Food and Drug Administration (FDA) researchers are working to develop a new informatics model to reduce the reliance on dogs to conduct studies in animal drug development.   The agency’s new study, which was proposed on Friday, is intended to aid animal drug developers in conducting certain research without the need for product testing on dogs.   Animal drug developers would be able to use the new model as a mechanism for comparing blood levels of certain oral...
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    CDRH Works on Clinical Objectivity in Patient-Reported Outcomes

    A new study conducted by mathematical statisticians at the US Food and Drug Administration (FDA) bridges the gap between an objective endpoint and a patient-reported outcome (PRO). The research , led by statisticians Chul Ahn and Xin Fang at FDA’s Center for Devices and Radiological Health (CDRH), seeks to arrive at an acceptable level of probability for a PRO measure to reveal the “truth” of a subject’s disease or health condition. It comes at time when the science of ...
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    FDA Finalizes Testicular Toxicity Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance for drugmakers on identifying and evaluating early signals that could indicate whether a drug might have adverse effects on the testes and when clinical trials are necessary to assess those risks.   Specifically, the 14-page guidance lays out recommendations for identifying nonclinical signals that suggest risk of testicular toxicity; conducting nonclinical assessments to further evaluate the ris...
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    Knowing Regulations Not Enough, Says Expert who Will Help Guide RAPS Exec Program Participants

    RAPS' long-running Executive Development Program , which brings rising regulatory leaders to the Kellogg School of Management at Northwestern University for four days of intensive business training, has been consistently popular because it fills an increasing need. Most regulatory professionals come from science- or engineering-oriented backgrounds, with relatively few having had business training or experience. The growing recognition of the strategic importance of regu...
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    GSK's Sue James Praises RAPS' Regulatory Competency Framework

    In 2016, RAPS released its Regulatory Competency Framework , a tool to help professionals and organizations develop regulatory training, and plan career and professional development. A few organizations began using the Framework immediately. We spoke to former RAPS Chair Sue James, who is vice president of global regulatory affairs at GlaxoSmithKline (GSK) Consumer Healthcare about the Framework and how it has been used at GSK. Regulatory Focus : What do you see as th...
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    Are You a Rising Regulatory Leader? Learn Business Skills at RAPS Executive Development Program

    As William C. Putnam, PhD, RAC, argues in a  Regulatory Focus  thought piece  on the need for business skills within the regulatory profession, "regulatory professionals need to have a comprehensive understanding of business, such as the business acumen provided by extensive on-the-job training, professional development programs or formal business training."  Regulatory Strategy Critical for Business Success The reasons for this are pretty clear. Regulatory issues can ...